Kornimate/medical-research-clean huggingface dataset:
effect of genetic alterations affecting the genes encoding the major enzymes of the kynurenine pathway on suicidal behavior

Conditions: Tryptophan Metabolism Alterations; Polymorphism; Suicidal Behavior

Summary: current research has shown that an imbalance in the kynurenine pathway plays a role in the physiopathology of neurogenerative and mental disorders (with a decrease in neuroprotective metabolites and an increase in neurotoxic products). so far the research has concentrated on the enzymes ido 1/2, kat (1-4), kmo and acmsd which are the key players in this pathway. several polymorphisms affecting these enzymes have been associated with certain disorders characterized by a deregulation of the inflammation and immune response (mccauley et al 2009,tardito et al 2013, lee et al 2014), but the link between these enzymes and suicidal behavior is not yet clear. the investigators hypothesize that people with history of suicide attempt would have a genetic alterations of the kynurenine pathway specific for suicidal behavior.


Eligibility criteria:
inclusion criteria: * for the "sucide attempters" group: any patient aged 18 or over who has made at least one suicide attempt. * for the two control groups: any patient aged 18 or over, suffering from depression but has never attempted to commit suicide and any healthy subject who has never had any mental disorders. exclusion criteria: * any patient who has expressed opposition to the use of his/her data.

Keywords: sucidal behavior inflammation kynurenines
dysphagia following anterior cervical spine surgery; steroid vs saline

Conditions: Dysphagia

Summary: this prospective, randomized, double blind, controlled study evaluates the effect of perioperative iv steroids versus saline on swallowing after anterior cervical spine surgery.

this investigation is a prospective, randomized, double-blind, controlled trial testing peri-operative steroids versus saline and the effect on swallowing after anterior cervical spine surgery. swallowing symptoms will be measured using the patient reported bazaz (bazaz) scale and the dysphagia short questionnaire (dsq). swallowing data will be obtained pre-operatively, one day and two days post-operatively and then one week, two weeks, four weeks, three months, six months, and one year post-operatively. patient clinical outcomes will be captured using web-based progress reports. patients will complete the quality of life (qol-12), neck disability index (ndi), and visual analog scale (vas) questionnaires electronically pre-operatively and at one year post-operatively. this outcome data will help us analyze the swallowing function or symptoms with the overall clinical course of the patients enrolled in this study.

Eligibility criteria:
inclusion criteria: * elective anterior approach to subaxial cervical spine (c3 - t1); * ages 18-80 exclusion criteria: * traumatic or tumor etiologies * undergoing anterior-posterior operations * neoplastic, or infectious conditions requiring surgery * a history of previous anterior cervical spine surgery * any patient requiring a halo vest * patients on chronic steroids * patients remaining intubated post-operatively (please see more under risks below) * less than 18 years of age * pregnant women * no phone
a study of the effectiveness of cabozantinib in combination with nivolumab as first-line treatment of advanced renal cell carcinoma (arcc) in adults

Conditions: Advanced Renal Cell Carcinoma

Summary: the purpose of this study is to collect data to describe the safety and effectiveness of cabozantinib and nivolumab in combination as a first-line treatment in adults with arcc with clear cell-component, according to real-world clinical practice. the decision to prescribe cabozantinib and nivolumab in combination will be made prior to, and independently from, the decision to enrol the participant in study.


Eligibility criteria:
inclusion criteria: * participants with diagnosis of arcc with clear-cell component * participants with no prior systemic treatment for arcc with clear-cell component; * physician-initiated decision to treat with cabozantinib and nivolumab in combination (prior to study enrolment), according to cabometyx® and opdivo® approved local labels; exclusion criteria: * current participation in an investigational program with any intervention which could possibly interfere the treatment and impact this study; * history of allergy or hypersensitivity to cabometyx® or opdivo® components.
exhaled nitric oxide as a biomarker of disease activity in eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: there is currently no reliable, noninvasive biomarker for eosinophilic esophagitis (eoe), a chronic allergic diseases characterized by significant infiltration of eosinophils in the esophagus. because eosinophils release nitric oxide, levels of exhaled nitric oxide (feno) are used routinely for guiding treatment in subsets of patients with asthma. feno levels are also elevated in immunological diseases that do not involve the airways. the investigators hypothesize that patients with eoe have elevated nitric oxide concentration in their exhaled breath and that changes in feno levels could be used to measure disease activity. the objective of this study is to determine the feasibility of using feno as a noninvasive surrogate marker for eoe disease activity. the investigators propose to measure serial exhaled nitric oxide (feno) levels on a group of patients with confirmed eoe, before, during and after the course of topical corticosteroid therapy to determine whether the level declines from pre-treatment level in individual patients.


Eligibility criteria:
inclusion criteria: * age 7-65. * confirmed diagnosis of eoe. the diagnosis of eosinophilic esophagitis is based upon the presence of characteristic clinical features and large numbers of eosinophils in the esophagus on pathologic examination (≥15 eosinophils per high powered \[400x\] field in at least one specimen) despite acid suppression with a ppi for one to two months. the criteria also include normal gastric and duodenal mucosal biopsies and the exclusion of other causes. clinical features in adults include dysphagia, pain and/or history of food impaction. symptoms in children vary depending in part upon their age: feeding disorders (median age 2.0), vomiting (median age 8.1), abdominal pain (median age 12.0), dysphagia (median age 13.4), and food impaction (median age 16.8). exclusion criteria: * use of systemic or inhaled corticosteroids in the preceding 3 months. * history of doctor-diagnosed asthma, acute or chronic rhinosinusitis. * history of cirrhosis. * history of kidney, heart or lung disease. * pregnancy

Keywords: exhaled nitric oxide eosinophilic esophagitis
daily-dose consensus interferon and ribavirin: efficacy of combined therapy

Conditions: Chronic Hepatitis C

Summary: this phase 3 clinical study is designed to evaluate the safety, tolerability, and efficacy of two dose levels of infergen (interferon alfacon-1, cifn) plus ribavirin administered daily for 48 weeks and no treatment in patients chronically infected with hepatitis c who are nonresponders to previous pegylated interferon alfa plus ribavirin therapy and participated during at least 24 weeks of no treatment in irhc-001. at the time of randomization into irhc-001, the no treatment arm patients will be concurrently randomized in a 1:1 ration to receive interferon alfacon-1 (9 or 15 µg) + ribavirin (both administered daily) or no treatment for up to 48 weeks. patients will not be eligible for consideration to receive treatment in irhc-002 until they have completed a minimum of 24 weeks of participation in irhc-001. the protocol and informed consent form that will be used must be approved by the investigator's institutional review board (irb)/independent ethics committee (iec) before the study is initiated.


Eligibility criteria:
(abbreviated due to space constraints.) inclusion criteria: 1. signed informed consent form 2. previously randomized to the no-treatment arm in irhc-001 protocol 3. irhc-001 no-treatment patients ho have either \< 2 log10 reduction in plasma hcv rna level by bdna assay at week 24 compared to baseline or detectable plasma hcv rna by bdna or tma assays at week 48 4. all patients and all potentially fertile sexual partners of patients must use 2 reliable forms of effective contraception during the study \& for 6 months after cessation of the study drugs exclusion criteria: 1. patients who experienced hepatic decompensation during irhc-001 or show laboratory, clinical, or physiologic evidence of hepatic decompensation at screening for irhc-002 2. patients who, in the opinion of the investigator or the sponsor, are not suitable candidates for enrollment or who would not comply w/the requirements of the study 3. pregnant or lactating women 4. male partners of women who are pregnant 5. patients who were on any experimental protocols or therapy while participating in irhc-001

Keywords: chronic hepatitis c liver pegylated interferon alpha ribavirin combination nonresponder hcv infergen svr
puregen: radiographic analysis of fusion for acdf

Conditions: Cervical Degenerative Disc Disease

Summary: the purpose of this study is to evaluate the rate and quality of spinal fusion utilizing puregen osteoprogenitor cell allograft in anterior cervical discectomy and fusion (acdf).

this is a prospective, multi-center, post-market, observational study assessing subjects undergoing cervical interbody fusion surgery to treat cervical degenerative disc disease (ddd) patients diagnosed with cervical degenerative disc disease will be screened for enrollment based on inclusion and exclusion criteria outlined in this protocol. subjects who are successfully screened and sign an informed consent will undergo acdf surgery utilizing puregen, alphagraft profuse demineralized bone scaffold (dbs), a radiolucent cervical interbody spacer, and trestle or reveal anterior cervical plating system (plate and screw fixation system). subjects will be followed at 6- weeks, 3-, 6-, and 12-month post-operative visits. standard radiographs will be taken at these visits to assess fusion rate and quality. sf-12, ndi and vas self assessment questionnaires and neurological exams will be administered to measure pain and function scores. a computerized tomography scan will be taken at the 6 month post operative exam to further assess rate and quality of fusion. a conditional 12-month post operative ct may also be taken. procedure related and device related adverse events will be monitored throughout the study. outcome data will be compared to published and/or retrospective data for the standard of care for ddd patients undergoing acdf.

Eligibility criteria:
inclusion criteria: * persistent neck and/or arm pain consistent to symptomatic cervical degenerative disc disease * moderate neck disability index * unresponsive to conservative treatment for at least 6 weeks exclusion criteria: * more than 4 levels requiring surgical treatment * prior failed fusion surgery at the index level(s) * systemic or local infection in the disc or cervical spine, past or present * active systemic disease * osteoporosis, osteomalacia, or other metabolic bone disease that would significantly inhibit bone healing * known or suspected history of alcohol and/or drug abuse * involved in pending litigation or worker's compensation relating to the spine * pregnant or plans to become pregnant during the duration of the study * insulin-dependent diabetes mellitus * life expectancy less than study duration * any significant psychological disturbance that in the opinion of the investigator could impair consent process or ability to complete self-assessment questionnaires * bmi greater than 40 * undergoing chemotherapy or radiation treatment, or chronic use of oral or injected steroids or prolonged use of non-steroidal anti-inflammatory drugs * known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (dmso).
effectiveness and biological mechanism of direct ischemic post-conditioning for acute stroke patients due to large vessel occlusion

Conditions: Stroke, Acute; Neuroprotection; Ischemic Conditioning

Summary: the goal of this clinical trial is to determine if direct ischemic post-conditioning (ipostc) can alleviate ischemic-reperfusion injury (i/r) in patients who have undergone endovascular thrombectomy (evt). additionally, the study aims to explore the underlying mechanisms of direct ipostc. the primary questions this trial seeks to answer are: 1. is direct ipostc effective for acute stroke patients with large vessel occlusion? 2. what are the underlying mechanisms of direct ipostc? participants will be randomly assigned to one of two groups: an evt alone group or an evt plus direct ipostc group. direct ipostc will be administered immediately after evt through four cycles of mechanical interruptions of reperfusion. we will evaluate outcomes based on final infarct volume, infarct volume growth, clinical parameters, and i/r-related imaging and laboratory biomarkers. additionally, an exploratory multi-omics analysis will be conducted to uncover the detailed mechanisms of direct ipostc.


Eligibility criteria:
inclusion criteria: 1. ischemic stroke confirmed by ct or mri. 2. large vessel occlusion confirmed by cta or mra, including the intracranial internal 3. carotid artery (ica) and middle cerebral artery (mca m1/m2). 4. recanalization of the occluded vessel at etici grade 2b/3, confirmed by dsa after thrombectomy. 5. the patient or legally authorized representative has signed an informed consent form. exclusion criteria: 1. inability to perform an mri or ct scan for any reason. 2. presence of any condition that would interfere with neurological assessment or any psychiatric disorders. 3. stroke onset accompanied by seizures, resulting in the inability to obtain an accurate nihss baseline. 4. pregnancy. 5. presence of other serious, advanced, or terminal illnesses.

Keywords: stroke, acute; large vessel occlusion; neuroprotection
permission to collect blood over time for research

Conditions: Pancreatic Cancer; Gastrointestinal Neoplasms; Colon Rectal Cancer Adenocarcinoma; Esophageal Cancer; Gall Bladder Cancer; Gastric (Stomach) Cancer; Gastrooesophageal Cancer; Gastrointestinal Stromal Tumor (GIST); Hepatobiliary Neoplasm; Liver Carcinoma; Gallbladder Carcinoma; Bile Duct Carcinoma; Carcinoma of the Large Intestine; Anal Cancer

Summary: to determine whether biomarkers assessed in blood samples can be used to detect individuals at risk for developing blood clots or worsening of their underlying disease. the ultimate goal of the study is to identify key biomarkers derived from blood that are most characteristic and informative of individuals who will go on to develop a clotting complication.


Eligibility criteria:
inclusion criteria: * male or female, \>= 18 years old. there are no ethnic restrictions. * active cancers of the gi tract (gastroesophageal, colorectal, or pancreatic-biliary) that have completed tnm staging by the american joint committee on cancer; stage iii disease if diagnosed within 2 months and all stage iv disease * ability to understand and the willingness to sign a written informed consent document. * existing staging ct imaging study exclusion criteria: * life expectancy \< 6 months * history of deep vein thrombosis (dvt) or pulmonary embolism (pe) * known pregnancy or positive urine pregnancy test in pre-menopausal women * on anticoagulant therapy (heparin, warfarin, direct thrombin inhibitors) * no ct imaging studies, or contraindications to undergoing ct imaging * existing or anticipated need for a tunneled central venous catheter * clinic visitation to stanford cancer center for secondary consultation purposes only * inability to give informed consent
surveys, blood testing, and fibroscan in screening for liver fibrosis and liver cirrhosis

Conditions: Liver and Intrahepatic Bile Duct Carcinoma

Summary: this clinical trial studies the use of surveys, blood testing, and fibroscan in screening for liver fibrosis and liver cirrhosis in new or existing patients of the hope clinic seeking usual clinical care. fibroscan is an imaging procedure of the liver which uses a probe like an ultrasound. information gathered from this study may help researchers learn more about how to prevent or find liver cancer in patients who are currently receiving care at the hope clinic. early detection of liver cancer may improve survival.

primary objective: i. to estimate the sensitivity of the modified center for disease control (cdc) hepatitis survey in diagnosing chronic hepatitis b virus (hbv) among hope clinic patient. secondary objectives: i. to estimate the sensitivity of the modified cdc hepatitis survey in identifying chronic active hepatitis c virus (hcv) infection among hope clinic patients. ii. to estimate the sensitivity of fibrosis serum biomarkers, non-alcoholic fatty liver disease fibrosis score (nfs), fibrosis-4 index (fib-4), and fatty liver index (fli) in detecting fibrosis (fibroscan result \>= f2) among hope clinic patients with metabolic conditions. iii. to estimate the sensitivity of the alcohol use disorder identification test alcohol consumption (audit-c) in identifying fibrosis (fibroscan result \>= f2) among hope clinic patients. iv. to estimate the sensitivity of the audit-10 survey in identifying fibrosis (fibroscan result \>= f2) among hope clinic patients who scored \>= 4 for men or \>= 3 for women on the audit-c. v. to estimate the specificity and accuracy of each of these risk factor screening tools in hope clinic patients. vi. to estimate the prevalence of fibrosis and cirrhosis risk factors among hope clinic patients. exploratory objectives: i. to explore factors associated with each fibrosis/cirrhosis risk factor. ii. to investigate differential diagnostic accuracy of screening methods by fibrosis severity. iii. to evaluate the diagnostic performance of each dichotomized biomarker (nfs, fib-4, and fli) separately and assess biomarker optimal cutpoints for identifying fibrosis in the study population. outline: patients complete surveys over 10-15 minutes, and undergo blood testing, clinical evaluation, and fibroscan at baseline. after completion of study, patients are followed up at 3 months.

Eligibility criteria:
inclusion criteria: * must be at least 18 years old * must be a new or existing patient of the hope clinic seeking usual clinical care * must be able to speak and read english or a language other than english for which there is a translator available on site at the hope clinic exclusion criteria: * known pregnancy at time of recruitment. the hope clinic will ask the female patients if they are pregnant, will ask the participants for their last menstrual period (lmp), and/or they will use the urine pregnancy test (upt) results in their electronic medical records
comparison of standard of care or treatment on protocol

Conditions: Stomach Cancer; Esophageal Cancer; Bladder Cancer; Skin Cancer; Lung Cancer; Uterine Cancer; Ovarian Cancer

Summary: patient will choose to either receive the standard of care according to national comprehensive cancer network (nccn) or approved guidelines for their condition or to be treated according to one arm of the protocol that they could not be enrolled on. the selection of the arm will be at physician discretion.

all patients failing to enroll in a specific therapeutic research protocol using fda approved drugs or ctms accepted therapies will be screened for this study. patients will be randomized (patient own choice) to either standard of care described in the nccn guidelines and published as peer-reviewed phase ii or iii studies which show an efficacy or to one of the arms of the protocol they fail to enroll in, as determined by the treating physician.

Eligibility criteria:
inclusion criteria: * patients must have a cancer requiring chemotherapy or radiotherapy exclusion criteria: * inability to comply with study and/or follow-up procedures * any contraindication per the fda notice to the selected drugs * pregnant (positive pregnancy test) or lactating. no effective means of contraception (men and women) in subjects of child-bearing potential

Keywords: inst 0813 standard of care
risperidone for the treatment of huntington's disease involuntary movements

Conditions: Huntington Disease; Chorea

Summary: the purpose of this study is to assess the safety and benefit of risperidone for the treatment of chorea (involuntary movements) in huntington's disease. risperidone is commonly used in clinical practice to treat chorea, however, it has not been approved by the food and drug administration (fda) to treat chorea. this study will examine 1) whether the investigators see mri changes with risperidone treatment and 2) whether sensors applied to the participants body can measure chorea and detect changes in chorea.


Eligibility criteria:
inclusion criteria: * manifest hd (diagnostic confidence level 4 + cag repeat ≥ 37 or family history of hd) * uhdrs total maximal chorea (tmc) ≥ 8 * uhdrs total functional capacity ≥ 5 * subject willing and able to provide written informed consent or legally authorized representative provides written informed consent and subject provides assent\* * between 18 and 65 years of age exclusion criteria: * use of antipsychotic, levodopa, dopamine agonist, monoamine oxidase inhibitor or other disallowed medication in the 30 days prior to the baseline visit (see section 4.2.5)\* * prior non-response to risperidone or intolerability to risperidone (in the investigator's opinion) * allergy or hypersensitivity to risperidone * dysphagia that in the investigator's opinion would preclude participation in the study * active suicidal ideation or psychiatric condition that in the investigator's opinion would preclude study participation * qtc \> 460 msec for women and qtc \> 450 msec for men on 12-lead ekg * history of cardiac arrhythmia or congenital long qt syndrome * significant renal impairment (creatinine clearance \ 2.5 times upper limit of normal or alkaline phosphatase or total bilirubin \> 2 times upper limit of normal) * active drug or alcohol abuse or dependence * pregnant or breast-feeding * any contraindication to mri (e.g. pacemakers, aneurysm clips, metallic prostheses, shrapnel fragments, claustrophobia) * history of active (clinically significant) skin disorder that would interfere with sensor adherence * history of allergic response to adhesives * pacemaker, aicd, or other implantable stimulator * use of an investigational drug in the 30 days prior to the baseline visit * inability to complete study activities, as determined by the study team * clinically significant parkinsonism as determined by expert investigator assessment
a study of abi-h2158-containing regimens in participants with chronic hepatitis b virus infection

Conditions: Chronic Hepatitis B

Summary: this phase 2a study will assess the safety, antiviral activity, and pharmacokinetics (pk) of abi-h2158 administered once daily for up to 72 weeks in combination with entecavir (etv) in participants with chronic hepatitis b virus (hbv) infection.


Eligibility criteria:
inclusion criteria: * body mass index of 18 - 36 kg/m\^2 and body weight ≥45 kg * hbeag ≥500 iu/ml at screening * in good general health except for chronic hbv infection for ≥6 months documented, for example, by at least two measurements of hbsag positivity and/or detectable hbv dna ≥6 months apart * lack of cirrhosis or advanced liver disease exclusion criteria: * prior treatment for chronic hbv infection with lamivudine, telbivudine, adefovir, standard of care nucleoside or nucleotide analogue (nrti), hbv core inhibitors, or an investigational agent for hbv infection * history or evidence of advanced liver disease or hepatic decompensation (including jaundice, ascites, portal hypertension, gastrointestinal bleeding, esophageal varices, hepatic encephalopathy) * history or presence of clinically significant medical conditions requiring frequent medical management or pharmacologic or surgical treatment

Keywords: hbv hepatitis b